A letter to the Federal Bureau of Investigation and the Department of Justice

A letter to the Federal Bureau of Investigation and the Department of Justice

Hooman Noorchashm
Philadelphia, PA

Dec 18, 2014 — Members of the FBI, attorneys general and members of the DOJ,

Many hundreds of women have died prematurely or unnecessarily using a medical device known as a power morcellator.

For details please read the following article (and associated links) in the WSJ by Mr. Jon Kamp and his colleagues on yesterday’s front page:
http://www.wsj.com/articles/how-fda-approved-hysterectomy-tools-it-now-disfavors-1418700781

These wrongful deaths have been the result of a very serious violation of the Code of Federal Regulation, Title 21, Section 803 on the part of several notable medical device manufacturers (notably including Johnson and Johnson and Karl Storz GmbH):
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803&showFR=1&subpartNode=21:8.0.1.1.3.1

These manufacturers were fully aware of the deadly hazard posed by their devices as early as 2006, but failed to report the adverse events to FDA to protect the public, as required by Title 21, Section 803 of the CFR:
http://www.bizjournals.com/pittsburgh/news/2014/05/30/j-j-alerted-in-2006-to-devices-surgical-risks.html?page=all

As a result, many women have died prematurely or unnecessarily because of this egregious violation of the Code of Federal Regulation. It is now your very serious duty to investigate this grave corporate wrong-doing and bring this deadly violation of the Code of Federal regulation to justice.

I ask that you act with resolve and consistent with your duty to the American public as officers in our system of justice. We await an opportunity to expose this corporate wrong-doing to our system of justice for judgement so as to prevent anything like it from ever devastating another family in the United States.

We ask that you look at this issue immediately and with care. Accepting reckless and criminal conduct by major corporations is not an option you can accept.

Very Sincerely,
HN

How FDA Approved Hysterectomy Tools It Now Disfavors
How FDA Approved Hysterectomy Tools It Now Disfavors
The Food and Drug Administration’s warning last month was unusual: Doctors shouldn’t use a common surgical tool on most women because it can spread hidden uterine cancer. A year earlier, the FDA had no official…
HTTP://WWW.WSJ.COM
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